This summer saw a flood of decisions involving Medtronic’s Infuse bone graft system from all across the country. State and federal courts ruled on defendant’s motions to dismiss and overwhelming agreed with Medtronic that the bulk of plaintiffs’ claims are preempted. Because the decisions were coming down so quickly, we decided to wait and bring them to you as a group. And, collectively they make quite a statement. That statement is that you can’t circumvent preemption by alleging off-label use.

For your convenience, here are the names and cites for all the favorable cases:

Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206 (W.D. Okla. 2013)

Dawson v. Medtronic, Inc., 2013 WL 4048850 (D.S.C. Aug. 9, 2013)

Gavin v. Medtronic, Inc., 2013 WL 3791612 (E.D. La. Jul. 19, 2013)

Harris v. Medtronic, 2013 WL 4011624 (Cal. Super. Aug. 1, 2013)

Houston v. Medtronic, Inc., ___ F. Supp.2d ___, 2013 WL 3927839 (C.D. Cal. Jul. 30, 2013)

Lawrence v. Medtronic, Inc., 2013 WL 4008821 (Minn. Dist. Ct. Aug. 7, 2013)

Otis-Wisher v. Fletcher Allen Health Care, Inc., __ F.Supp.2d ___, 2013 WL 3214714 (D. Vt. Jun. 25, 2013)

Wendt v. Bernstein, 2013 WL 3199361 (Ill. Cir. Ct. Jun. 24, 2013)

To be fair, we are aware of two others: Ramirez v. Medtronic, Inc., 2013 WL 4446913 (D. Ariz. Aug. 21, 2013) and Alton v. Medtronic, Inc., 2013 WL 4786381 (D. Or. Sept. 6, 2013). But they don’t make our list because they went the other way – finding most of plaintiffs’ state-law claims weren’t preempted because they were premised on off-label promotion. But these are cases out of the Ninth Circuit and as such are burdened by that court’s decision in Stengel v. Medtronic Inc., 704 F.3d 1226 (9th Cir. 2013) (en banc) allowing a negligent failure to warn claim (see our post here). So, much of the reasoning that held the day across the country wasn’t as persuasive out west. That should mean their influence is geographically limited. Their authority is further undercut by the fact that courts themselves don’t agree. SeeAlton at *22 (disagreeing with Ramirez). But, with the count at 8 to 2, we’ll let you check out Ramirez and Alton on your own and instead focus on the good stuff. We’ve said before, and we’ll say it again, as a defense blog, we don’t do the other side’s research for them.

The claims in all these cases are more or less the same. The Infuse bone graft system is a Class III medical device approved by the FDA through the Premarket Approval (“PMA”) process. Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206, 1210 (W.D. Okla. 2013). The system was approved as a medical device consisting of three parts for use in anterior (through the abdomen) lumbar surgery. Plaintiffs allege that the device was used off-label in their posterior (through the back) surgeries and/or because only one piece of the system was implanted.

Express and Implied Preemption: Medtronic is no stranger to the body of law surrounding PMA medical devices. Because the Infuse Device is a PMA medical device, it brings into play §360k of the Food, Drug and Cosmetic Act (“FDCA”)which expressly preempts any state-law claim that is “different from or in addition to” the FDA’s regulation. Express preemption of traditional state-law strict products liability, breach of warranty, and negligence claims for PMA devices has been settled since Riegel v. Medtronic, 552 U.S. 312 (2008). But, the cases haven’t gone completely away due to Riegel’s“parallel violation” claim. If a plaintiff’s claims are premised on a violation of FDA regulations, they are parallel to those regulations, rather than additional or different, and thus not preempted. Deciding what is and is not a parallel violation claim has been the meat and potatoes of medical device litigation for the last five years. But it is not without its own checks – implied preemption and no private cause of action.

That is, plaintiff can’t sue a medical device manufacturer for violating the FDCA. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) made clear that such a claim can only be brought by the federal government, not private citizens. To avoid implied preemption, plaintiff must bring a valid state-law claim that is based on conduct that violates the FDCA. The interplay between express and implied preemption for PMA medical devices can be summed up as follows:

Riegel and Buckman create a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).
 

In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir.2010). In other words, “the plaintiff must allege that a well-recognized duty owed under state law was breached by a manufacturer’s conduct that violates the FDCA.” Gavin v. Medtronic, Inc., 2013 WL 3791612, *5 (E.D. La. Jul. 19, 2013). Plaintiffs in the Infuse litigation tried to use off-label use to dodge both types of preemption but they were unsuccessful in sliding through that “narrow gap.” Here is how the courts dispensed of plaintiffs’ claims.

Off-Label Use and Express Preemption: Riegel establishes a two-step test to determine whether plaintiff’s claims are expressly preempted. Step one is “whether the FDA has established requirements for the subject device.” Houston v. Medtronic, Inc., ___ F. Supp.2d ___, 2013 WL 3927839, at *6 (C.D. Cal. Jul. 30, 2013). And the Supreme Court concluded that the rigorous PMA process “imposes requirements under the MDA.” 552 U.S. at 322. But plaintiffs didn’t want this to be the end of the inquiry, so they “sought to convince the Court[s] that the FDA’s premarket approval applies only to the Infuse device in its on-label usage.” Lawrence v. Medtronic, Inc., 2013 WL 4008821 (Minn. Dist. Ct. Aug. 7, 2013). SeeCaplinger, 921 F.Supp.2d at 1217; Houston, 2013 WL 3927839 at *7; Gavin, 2013 WL 3791612 at *11. Plaintiffs argued that §360k should not preempt any state law claim that arises from off-label use.

First, it must be said that plaintiffs’ “argument is clearly inconsistent with Riegel which also involved the off-label use of a medical device.” Gavin at *12. More importantly, it is well-established that the FDA regulates the device, not just a particular use.

[U]nder § 360k(a)(1), the question is not whether there are federal requirements applicable to a particular use of a device; the question is whether there are federal requirements applicable “to the device.”If there are—and, as Riegel makes clear, the PMA process unquestionably imposes such requirements—then any state requirements that are different from, or in addition to, those federal requirements are preempted. Nothing in the statute suggests that the preemption analysis somehow depends on how the device is used.

Caplinger, 921 F.Supp.2d at 1219 (quoting Riley v. Cordis Corp., 625 F.Supp.2d 769, 779 (D.Minn. 2009). The Houston court summed it nicely as well:

Thus, even though Plaintiff was not implanted with the Infuse Device in an approved manner, her state claims are oriented “with respect to” the off-label promotion and use of a device that is covered by federal requirements. This suffices to bring her state law claims within the ambit of express preemption under Riegel.
 

Houston, at *7. See alsoGavin, at *11 (“nothing in §360k(a) or Riegel suggests that applicability of the preemption analysis depends on hour the device is being promoted to be used.”); Harris v. Medtronic, 2013 WL 4011624 (Cal. Super. Aug. 1, 2013) (express preemption “cannot be avoided by trying to distinguish between off-label uses of such devices. The PMA covers devices – not applications.”).

After rejecting plaintiffs’ arguments that express preemption doesn’t apply to off-label usage, each court moved onto to step two of the Riegel test – whether any of plaintiffs’ state-law claims are different from or in addition to FDA requirements. SeeHouston at *7. On some claims, all the courts agree. All claims based on warnings and labeling (whether sounding in negligence, strict liability, fraud, or misrepresentation) are expressly preempted – with the exception of a Hughes v. Boston Scientific Corp., 631 F.3d 762 (5thCir. 2011) claim in Louisiana (this post is long enough already, so we’ll just point you here for a discussion of everything we don’t like about Hughes). Likewise, the courts agreed that plaintiffs’ design defect claims were expressly preempted. And, those that considered it held breach of implied warranty claims were also preempted. See also Dawson v. Medtronic, Inc., 2013 WL 4048850, *7 (D.S.C. Aug. 9, 2013).

Most of the courts were generally in agreement that it may be possible for plaintiffs to state a non-preempted fraud claim. If plaintiffs claimed that defendant made fraudulent statements in marketing and promoting the Infuse device, such claims are traditional state-law claims that run parallel to the federal requirement that manufacturers’ representations “not be false or misleading.” Houston, at *10. Unfortunately, the Houston court used this same reasoning to hold plaintiffs’ breach of express warranty claim was also not preempted (all other express warranty claims were dismissed). Id.at *11. But the courts were only able to say that such fraud (and warranty) claims have the “potential to escape”preemption because plaintiffs failed to plead them with the specificity required by the rules of civil procedure. See Lawrence, 2103 WL 4008821; Houston, at *10, *11; Caplinger, 921 F.Supp.2d at 1220. As we’ve seen time and time again, they reason they don’t plead them with specificity is because they can’t. So, even with leave to amend, these claims may never rebound.

Off-Label Use and Parallel Claims: Having not been successful in removing themselves from the realm of express preemption, plaintiffs’ second argument was that they were asserting non-preempted parallel violation claims. Plaintiffs claimed that defendant promoted and marketed the Infuse device for off-label uses and that this claim was a proper “parallel violation” claim that merely enforced the FDA’s prohibition of off-label promotion. There is a fundamental problem with such a claim. There is no state law to run parallel to anything:

While plaintiff's allegations regarding defendants' practice of promoting and marketing to physicians the off-label use of the Infuse Device in posterior-approach lumbar spine surgery could be a violation of the FDCA and, thus, plaintiff's claim would not be expressly preempted under §360k(a), plaintiff's negligence claim based upon defendants' promotion and marketing of the Infuse Device is not based on conduct that would give rise to a recovery under state law even in the absence of the FDCA. . . . [T]he conduct plaintiff complains of—how defendants are promoting and marketing to physicians the off-label use of the Infuse Device in posterior-approach lumbar spine surgery—is governed by the FDCA. To determine whether said conduct is improper would require reliance on the requirements of the FDCA. Further, even the concept of “off-label use” is a creature of the FDCA, is defined by the FDCA, and is not a part of [state] substantive law. While plaintiff couches her claim as a state law negligence claim, this claim is, in substance, a claim for violating the FDCA and, thus, is clearly preempted under Buckman.
 

Caplinger, 921 F.Supp.2d at 1223-24. The Gavincourt reached a similar conclusion:

There is no Louisiana state law claim premised on off-label promotion. Indeed, the very concept of “off-label” use and promotion is derived from the regulatory system imposed by the MDA and the FDCA.
 

Gavin, at *17. Further,“[p]ermitting this claim to proceed would essentially allow a private litigant to attempt to enforce the FDCA.” Houston, at *8 (“any negligence claim based solely on illegal off-label promotion is impliedly preempted). See also Wendt v. Bernstein, 2013 WL 3199361 (Ill. Cir. Ct. Jun. 24, 2013) (“to the extent that the claims alleged here are seeking to enforce provisions of the FDCA, they would be impliedly preempted.”). In other words, plaintiffs really weren’t bringing state law claims. They were trying to enforce the provisions of the FDCA. But that’s not allowed.

As much as plaintiffs had failed to allege a valid state-law claim, they equally failed to allege what federal law was violated. Plaintiffs failed both to allege conduct that violates the FDCA and failed to allege which FDA regulations were violated. The first point was highlighted by the Dawson court. Plaintiffs tied almost all of their claims to off-label promotion, alleged that off-label promotion violated the FDCA and that therefore, all of their claims were parallel. Dawson, 2013 WL 4048850 at *6. Their argument, however, missed the mark in a significant way:

[F]or any of these claims to survive . . . the court must accept Plaintiff’s premise that off-label promotion is illegal under the FDCA, and this court cannot do so. . . . This court is not convinced that off-label promotion violates the FDCA. Consequently, any state laws proscribing off-label promotion would establish requirements “different from[] or in addition to[] any requirement” under the MDA and would be expressly preempted.
 

Id. See also Lawrence, 2103 WL 4008821 (“This court does not necessarily agree that federal law prohibits all promotion of off-label uses of medical devices.”).

Moreover, plaintiff “cannot simply incant the magic words Medtronic violated FDA regulations in order to avoid preemption.” In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F.Supp.2d 1147, 1158 (D.Minn.2009). This was most evident in Otis-Wisher v. Fletcher Allen Health Care, Inc., __ F.Supp.2d ___, 2013 WL 3214714 (D. Vt. Jun. 25, 2013), where the court held that plaintiff“must allege in detail the federal requirement allegedly violated.” Id.at *4. The court found that at best plaintiff alleged failure to comply with “federal law and regulations,” but that because the allegation did “not state a device specific violation of federal law, it is not sufficient to avoid preemption.” Id.at *5.

Phew. That’s a lot of information. And, it is overwhelming favorable. Courts (certainly courts outside the Ninth Circuit) seem to be understanding that except in very rare circumstances off-label promotion claims are either preempted, invalid attempts by private citizens to enforce FDA regulations, or simply don’t involve conduct that violates the FDCA. Roll that altogether and there’s not much left for plaintiffs to try to thread through the needle.